Following reports that Omontys is causing severe allergic reactions and even deaths among kidney-disease patients, the US Food and Drug Administration revealed that Affymax and Takeda Pharmaceuticals have initiated a recall of their anemia injection.
According to Affymax, around 25,000 patients have been treated with Omontys so far with 0.2 percent, or 50 patients, experiencing hypersensitivity, where the immune system reacts to drugs and other foreign objects, and around five people have reportedly lost their lives.
"Due to the severity of the public health risk, we want to be certain that health care providers stop using Omontys. Americans deserve medications that are safe, effective, and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more", FDA's Howard Sklamberg said.